19041

Elemental Impurities according to ICH Q3D oral, Standard 1

TraceCERT^®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

• Synonyme(s) : TraceCERT Elemental Impurities according to ICH Q3D oral
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; TraceCERT^®
• Niveau de qualité: 300
• Agence: according to ICH Q3D; according to Ph. Eur.; according to USP
• Gamme de produits: TraceCERT^®
• Durée de conservation: limited shelf life, expiry date on the label
• Composition: Ag, 150 mg/L ; As, 15 mg/L ; Cd, 5 mg/L ; Co, 50 mg/L ; Hg, 30 mg/L ; Ni, 200 mg/L ; Pb, 5 mg/L ; Se, 150 mg/L ; Tl, 8 mg/L ; V, 100 mg/L
• Concentration: (in 12% nitric acid)
• Technique(s): ICP: suitable
• Format: multi-component solution

Description

Description générale

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034). This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

Application

• Compatibility of oral magnesium oxide with ICH-Q3D: A study assessing the compatibility of oral magnesium oxide preparations with ICH-Q3D guidelines for elemental impurities ensures compliance with global standards, enhancing drug safety and efficacy (Satoh et al., 2021).

Notes préparatoires

For the preparation of this CRM only materials of highest purity were used.

Informations légales

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

Informations sur la sécurité

• Pictogrammes: GHS05
• Mention d'avertissement: Danger
• Mentions de danger: H290,H314,H412
• Conseils de prudence: P234 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Classification des risques: Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• Risques supp: EUH071
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable